Dear All
The Indian regulatory authority CDSCO has issued new
draft rules relating to the approval of clinical trials. In the draft rules, all clinical trials must be registered at the
Clinical Trial Registry - India (CTRI) before enrolling the first patient in the study. The trial sponsor or clinical trial organization must allow trial site inspection without notice by the Central Drugs Standard Control Organization.
Also published
draft rules on the registration of ethics committees in India, and
draft rules on the calculation of compensation for any injury or death resulting from a clinical trial.
India - CDSCO Issues Draft Rules for Clinical Studies - 2012
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